1. Field of the Invention
This invention is concerned with novel sterilization techniques, particularly with techniques involved with sterilization of multi-component medical device implants of which components have varying degrees of resiliency dependent on the sterilization technique.
2. Related Art
Sterilization is a key step in providing safe and efficacious products, particularly for implantable medical devices.
Currently medical devices are terminally sterilized using a variety of methods, such as ethylene oxide, gamma sterilization. For products that are in a liquid form, sub-micron filters may be used to sterilize the product. However, there are some devices that might require combinations of components that may not be compatible with the same sterilization method. For example, a mixture of a growth factor with a scaffold. In this instance, the two components may be separately sterilized or aseptically processed using the appropriate method and are then brought together aseptically at the final stage of processing. Due to the open nature of the aseptic processing, there is always a chance of contamination, leading to the rejection of the product lot.
Alternately, the combined product may be terminally sterilized, wherein the final product may be sterilized by conventional sterilization techniques such as by ethylene oxide or gamma irradiation. However, terminal sterilization techniques may affect the efficacy or other physical properties of the combined medical device.
Therefore, there is a need for novel methods and devices that are adaptable to sterilizing multiple components that have different degrees of resiliency to sterilization techniques such as may occur when a single terminal sterilization technique is used on a combination of components of a device that may be adequate for one of the components but may destroy the efficacy of the other component(s). One such advance in sterilization techniques is provided for by the invention hereinafter disclosed.